Xiflodrop

Package Leaflet: Information for the Patient

Xiflodrop, 5 mg/ml, Eye Drops, Solution

Moxifloxacin

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Xiflodrop and what is it used for
• 2. Important information before using Xiflodrop
• 3. How to use Xiflodrop
• 4. Possible side effects
• 5. How to store Xiflodrop
• 6. Contents of the pack and other information

1. What is Xiflodrop and what is it used for

Xiflodrop eye drops are used to treat bacterial eye infections (conjunctivitis).
The active substance of the medicine is moxifloxacin, an ophthalmic anti-infective agent.

2. Important information before using Xiflodrop

When not to use Xiflodrop:

• if you are allergic to moxifloxacin, other quinolones (a type of antibiotic) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Xiflodrop, discuss it with your doctor or pharmacist.

• If you have experienced allergic reactions to Xiflodrop. Allergic reactions occur not very often, and severe allergic reactions occur rarely. If you experience any allergic reactions (hypersensitivity) or any other side effects, follow the instructions in section 4.
• If you use contact lenses - you should stop using them when you have symptoms of eye infection. Instead, use glasses. Do not wear contact lenses until the symptoms of eye infection have resolved and you have finished using the medicine.
• In patients receiving fluoroquinolones orally or intravenously, there have been cases of swelling and tendon rupture, especially in elderly patients and those treated with corticosteroids at the same time. You should stop using Xiflodrop if you experience pain or swelling of the tendons.

Like any other antibiotic, long-term use of Xiflodrop may lead to the development of other infections.

Xiflodrop and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take, including those that are available without a prescription.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

For a short time after using Xiflodrop, your vision may be blurred. Do not drive or operate machinery until your vision is clear.

3. How to use Xiflodrop

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Xiflodrop is for use in the eye only.
The recommended dose is:
Adults, including the elderly and children: 1 drop into the affected eye(s) 3 times a day (morning, afternoon and evening).
Xiflodrop can be used in children, in patients over 65 years of age, and in patients with kidney and liver diseases. The use of this medicine is not recommended in newborns, as there is only limited information available on its use in these patients.
This medicine should be used in both eyes only if your doctor has told you to do so.
Xiflodrop is for use in the eye only.
The infection usually clears up within 5 days. If you do not see an improvement, you should contact your doctor. You should continue using the drops for a further 2-3 days or as long as your doctor tells you.

How to use Xiflodrop

1 2 3

• Prepare the Xiflodrop bottle and stand in front of a mirror.
• Wash your hands.
• Remove the cap.
• If the protective collar is loose after removing the cap, it should be removed before using the medicine.
• Hold the inverted bottle between your thumb and middle finger.
• Tilt your head back. With a clean finger, gently pull the lower eyelid down to create a "pocket"; the drop should fall into this pocket (see picture 1).
• Bring the tip of the bottle close to the eye. You can use a mirror to help.
• Do not touch the dropper to the eye or eyelid, or to any other surface.This could lead to contamination of the drops.
• Gently squeeze the bottom of the bottle to release one drop of medicine (see picture 2).
• Do not press the bottle too hard. It is designed so that a gentle squeeze on the bottom is enough.
• After using Xiflodrop, press the corner of your eye with your finger for 2-3 minutes (see picture 3). This helps prevent the medicine from getting into the rest of your body, which is especially important in small children.
• 3. This helps prevent the medicine from getting into the rest of your body, which is especially important in small children.
• If you are using drops in both eyes, you should wash your hands before repeating the above steps for the other eye. This helps prevent transferring infection from one eye to the other.
• Replace the cap immediately after use.

If the drop does not fall into the eye, try again.
If you use more Xiflodrop than you should,rinse your eyes with warm water. Do not use any more drops until it is time for your next dose.
If you accidentally swallow Xiflodrop,contact your doctor or pharmacist for advice.
If you miss a dose of Xiflodrop,continue with the next dose as planned. Do notuse a double dose to make up for a forgotten dose.
If you are using other eye drops,leave at least 5 minutes between using Xiflodrop and the other drops.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Xiflodrop can cause side effects, although not everybody gets them.
You can usually continue using the drops as long as the side effects are not serious or if you do not experience severe allergic reactions.
If you experience a severe allergic reaction or any of the following symptoms, stop using Xiflodrop and tell your doctor right away: swelling of hands, feet, ankles, face, lips, mouth or throat which may cause difficulty in swallowing or breathing, rash or urticaria, large blisters, sores or ulcers.
Common side effects(may affect up to 1 in 10 people)
Eye symptoms:eye pain, eye irritation
Uncommon side effects(may affect up to 1 in 100 people)
Eye symptoms:dry eye, eye itching, eye redness, inflammation of the surface of the eye or scarring, broken blood vessel in the eye, abnormal sensation in the eye, abnormalities of the eyelids, itching, redness or swelling.
General symptoms:headache, unpleasant taste in the mouth.
Rare side effects(may affect up to 1 in 1,000 people)
Eye symptoms:corneal disease, blurred or decreased vision, conjunctivitis or eye infection, eye strain, eye swelling.
General symptoms:vomiting, discomfort in the nose, feeling of lumps in the throat, decreased iron levels in the blood, abnormal liver test results, abnormal sensation on the skin, pain, throat irritation.
Unknown(frequency cannot be estimated from the available data)
Eye symptoms:eye infection, clouding of the surface of the eye, corneal swelling, deposits on the surface of the eye, increased pressure in the eye, scratching on the surface of the eye, eye allergy, eye discharge, increased tear production, sensitivity to light.
General symptoms:shortness of breath, irregular heartbeat, dizziness, worsening of allergic symptoms, itching, rash, redness of the skin, nausea and urticaria.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist or nurse. You can also report side effects directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xiflodrop

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and carton after: EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
To prevent infections, the bottle should be discarded 4 weeks after it is first opened.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Xiflodrop contains

• The active substance is moxifloxacin. 1 ml of eye drops contains 5 mg of moxifloxacin (as 5.45 mg of moxifloxacin hydrochloride). One drop contains 190 micrograms of moxifloxacin.
• The other ingredients are: boric acid, sodium chloride, sodium hydroxide to adjust pH, water for injections.

What Xiflodrop looks like and contents of the pack

Xiflodrop is a clear, greenish-yellow solution, available in packs containing 1 plastic bottle of 5 ml solution.
Not all pack sizes may be marketed.

Marketing authorization holder

BAUSCH + LOMB IRELAND LIMITED
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

Famar S.A.
Plant A, 63 Agiou Dimitriou str.
174 56 Alimos, Athens
Greece
Pharmathen S.A.
6 Dervenakion str.
15351 Pallini, Attiki
Greece

Date of last revision of the leaflet: